DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/02/2025 has been considered by the examiner.
Status of the Claims
The amendment filed 12/02/2025 is under consideration.
Claims 1, 8, 9, 10, 11, 14, 15, 16, 17, and 18 are pending.
Claims 1 and 18 are independent
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Amendment
Claim 1 has been amended to require the inner surface is provided with a coating comprising 0.13-0.17 mass parts of hyaluronic acid or its salt thereof, 13-17 mass parts of glycerin, and 1-5 mass parts of butylene glycol, and the coating on the inner surface of the glove increases skin hydration of the subject's hand upon contact therewith.
This combination of limitations has not been previously presented.
Withdrawn
The objection to claims 13-15 is withdrawn because of Applicant’s amendment.
The rejection of claims 3-11 and 13-15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
The rejection of claims 1-2, 12, 16-18 and 20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Cai, CN 106361680 A has been withdrawn because of Applicant’s amendment.
Claims 1-2, 16, 18 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Thai, US 20150135404 A1 has been withdrawn because of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive.
1. Applicant argues the ratio range of hyaluronic acid, glycerin, and butylene glycol in the coating of the claimed glove is of critical importance.
Applicant argues the examples show that even when glove coating compositions comprise each of hyaluronic acid, glycerin, and butylene glycol, skin hydration results demonstrate significantly distinct differences in glove-wearing experiments depending on the specific proportional ratios of these three components.
Applicant argues that using gloves prepared with the claimed coating compositions according to claim 1, Group Al exhibited a 14.5 + 2.17% change in skin hydration, indicating increased skin hydration (Specification, Table 1, Group A1), whereas Group G5 showed only a 4.7 + 1.55% change (Specification, Table 3, Group G5. Applicant argues this represents a >3-fold difference in efficacy (14.5% vs. 4.7%), indicating that proportional ratios critically determine performance.
These arguments are unpersuasive.
Applicant’s proffered results, arguendo, even if found to be unexpected, which is not stipulated, are not commensurate in scope with the invention as claimed.
The claimed invention is not limited to a glove having the coating composition found in embodiment A1.
The claimed invention is only limited by the mass parts of each component. However, the claimed invention is not limited to a discrete amount of each component as found in the exemplified compositions. That is, the composition in A1 is defined by more than just 0.16 mass parts of sodium hyaluronate, 14 mass parts glycerine, and 2 mass parts butylene glycol because the exemplified composition is additionally defined by discrete amounts of each component relative to the total mass of the composition. For example, in addition to the recited mass parts, composition A1 is defined by (0.16/16.16x100%) = 1% sodium hyaluronate based on the total mass of the coating composition. Similarly, A1 has (14/16.16 x 100%) = 86% glycerine based on the total mass of the coating composition, and (2/16.16 x 100%) = 12.3% butylene glycol based on the total mass of the coating composition. These percentages by total mass are not limitations of the claimed invention. If the amounts were found to be critical, then the claimed invention needs to include the % by total mass for each component to be commensurate in scope with the proffered data. Further, each of the claimed components are clearly within the percent by mass ranges suggested by Thai and Sugawara. Thus, even if the amounts of each exemplified component were found to be critical, the claimed invention is not limited to the compositions used to obtain the proffered data.
Significantly distinct, as argued, is not the same as a statistically significant unexpected result. Significantly distinct means there is actually a statistical difference in the observed moisturization values, but does not show evidence of a statistically significant, unexpectedly greater, degree of moisturization. Applicant’s data does not establish that the difference in degree of skin hydration is unexpectedly greater within the claimed ranges.
Evidence of criticality may be shown with an unexpected result. See MPEP 2144.05, III, A.
Comparing A1 with G5:
Both A1 and G5 show the expected result of improved skin hydration.
Comparing A1 with G5 shows increasing the amount of both glycerin and sodium hyaluronate increases hydration of skin. A1 contains more sodium hyaluronate and glycerin compared to G5. Two variables are changed. Moreover, it is not clear that a 3-fold increase in skin hydration is an improvement to an unexpected and statistically significant degree which would clearly establish an unexpected result. There is almost three times more glycerine and a higher amount of hyaluronate in A1 compared to G5.
Increased hydration is an expected effect since hyaluronic acid is a moisturizing agent which cooperates with polyvalent alcohols such as glycerine to exhibit moisturizing function (Sugawara, e.g., 0084). Glycerine was also a known moisturizing agent. See Thai, e.g., 0028: examples of moisturizers include glycerin and butylene glycol.
Further, Sugawara teaches optimizing the relative amounts of hyaluronate and polyvalent alcohols since hyaluronate is expensive and a lesser amount of hyaluronate is required to achieve similar skin moisturizing effect in combination with polyvalent alcohols such as glycerin and butylene glycol (Sugawara, e.g., 0013).
Since glycerine and hyaluronate are moisturizing agents, the skilled artisan would have expected increased moisturization from increased content of moisturizing agents.
Expected beneficial results are evidence of obviousness. See MPEP 716.02(c), II.
Applicant has argued that in the glove-wearing experiments, changes in skin hydration for the gloves prepared with the claimed coating compositions according to claim 1 consistently reach at least 12.1% + 2.17% (see Specification, Table 1, Group A1, Table 2, Group E17, Table 3, Groups H1, H4, H7, H10, and H13).
This argument is unpersuasive.
Comparing A1, E17, H1, H4, H7, and H13:
It is true that the results are consistent, but this is an expected result based on the fact that the same moisturizing ingredients are present in consistent amounts. Further, it is reiterated that the claimed invention is not commensurate in scope with the invention as claimed since the disclosed embodiments are further limited by discrete amounts of each component relative to the total mass of the composition.
2. Applicant argues the ratio range of hyaluronic acid, glycerin, and butylene glycol in the coating of the claimed glove yields unexpectedly superior skin hydration change (>12.1% change).
Applicant argues Sugawara's disclosure would have taught skilled artisans toward prioritizing high glycerin content (e.g., 97.970-99.470% as per Sugawara's Fig. 3, Examples 1-3).
This argument is unpersuasive.
Sugawara, Fig. 3 and Examples 1-3 only teaches 97.970-99.470% in the absence of butylene glycol. When present in combination with butylene glycol, Sugawara teaches significantly less glycerine is required, e.g., about 10-50% by mass of the composition. Thus, Sugawara would not have led the skilled artisan to a moisturizing formulation having 97.97-99.4% glycerin when the composition further comprises hyaluronate and butylene glycol.
Applicant argues the present application demonstrates that Group G4-featuring a substantially increased glycerin ratio in its coating composition-achieves a merely 6.1%
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1.37% change in skin hydration (Specification, Table 3, Group G4), which is significantly lower than the 14.5% + 2.17% improvement attained by Group Al.
Applicant argues reducing the glycerin ratio in the coating composition proves equally detrimental. Applicant argues Group G5, wherein the ratio of glycerin was substantially decreased, the resultant change in skin hydration plummeted to a mere 4.7% ±1.55% (Specification, Table 3, Group G5), substantially below the >12.1% minimum efficacy threshold achievable by the claimed formulations.
Applicant has argued that as shown in Group G2, an excessive sodium hyaluronate ratio in the coating composition likewise causes dramatic degradation in efficacy (Specification, Table 3, Group G2). Applicant argues that despite containing substantially more sodium hyaluronate (0.3 mass parts) than the preferred embodiments (e.g., Group A1: 0.16 mass parts), Group G2 achieves only 7.1%+2.39% change in skin hydration which is less than half the performance of A1.
These arguments are unpersuasive.
Applicant’s proffered results regarding glycerine appear to be optimization of a known moisturizing agent to maximize the expected result of moisturization. This is routine optimization of a known result effective variable to achieve expected results using routine methods. See MPEP 2144.05, II. The claimed invention is not limited to the composition disclosed in A1. In addition to differences in glycerin, G4 also contains less sodium hyaluronate. Therefore, it is not clear the difference in moisturization is solely the effect of different glycerine amounts. Comparing G4 and G5 the observed values for moisturization appear to overlap taking into consideration the standard deviations reported. Thus, from a comparison of G4 and G5 it appears the amount of glycerine is not critical.
Applicant’s proffered results regarding sodium hyaluronate appear to be optimization of a known moisturizing agent to maximize the expected result. This is routine optimization of a known result effective variable to achieve expected results using routine methods. See MPEP 2144.05, II. The claimed invention is not limited to the composition in A1. Also, G2 contains about 1/3 less glycerine compared to A1. Therefore, it is not clear that the differences are significant and unexpected or sufficient to demonstrate criticality for the amount of sodium hyaluronate.
Applicant has argued the prior art also fails to recognize the unexpected superiority of butylene glycol over propylene glycol in synergistic combination with hyaluronic acid and glycerin. Applicant has argued that while Sugawara indicates no meaningful distinction between propylene glycol and butylene glycol for moisturization, experimental data herein (e.g., Specification, Table 1, Group Al vs. Group A2, or Table 2, Group B8 vs. Group B9) indicates otherwise.
This argument is unpersuasive.
The moisturization difference between A1 and A2 is within the standard deviation between the two results. A1 is 14.5 + 2.17 and A2 is 13.75 + 2.09. These are overlapping ranges. This data is insufficient to establish an unexpected superiority of butylene glycol over propylene glycol in synergistic combination with hyaluronic acid and glycerin.
Similarly, the moisturization difference between B8 and B9 is within the standard deviation. B8 shows 9.5 + 2.17 and B9 shows 6.98 + 2.05. These are overlapping ranges. This data is insufficient to establish an unexpected superiority of butylene glycol over propylene glycol in synergistic combination with hyaluronic acid and glycerin.
3. Applicant argues the present invention relates to a coating composition for glove inner surfaces, while Sugawara discloses a cosmetic composition for topical application. These represent distinct technical fields with wholly disparate operational contexts
Applicant argues the coating composition in the claimed glove is applied as an inner-surface layer of gloves, designed to: (1) enhance skin hydration via direct contact during wear; (2) maintain robust adhesion to latex substrates; (3) preserve glove mechanical properties (tensile strength >25 MPa; elongation >500%); and (4) deliver sustained hydration in occlusive environments. Applicant argues the claimed solution involves a coating composition applied to the glove's inner surface to enhance skin hydration through direct contact during wear. Applicant argues Sugawara's cosmetic formulation fundamentally differs in purpose and technical constraints. Applicant argues cosmetics prioritize instant hydration and sensory comfort with compositions emphasizing safety and mildness, while glove coatings require mechanical robustness (stretch resistance) and persistent adhesion-beyond mere hydration-to withstand prolonged use. Applicant argues cosmetic and glove coating compositions exhibit irreducible differences in carrier systems, usage conditions, and functional demands, precluding direct interchangeability. Consequently, a skilled artisan would not adapt Sugawara's cosmetic solution to the claimed glove coating context.
These arguments are unpersuasive.
Both Thai and Sugawara are concerned with solving known problems of skin dryness. Both Thai and Sugawara teach compositions for moisturizing skin, wherein the compositions comprise hyaluronate and polyols including glycerine and butylene glycol specifically for moisturizing skin. Thai’s composition is applied directly to skin like Sugawara’s composition. Cai suggests compositions like those of Sugawara would be effective for skin care when incorporated in a glove. The present application does not proffer any objective evidence commensurate in scope with the claimed invention which shows the composition offers an unexpected result regarding points 2 or 3 as argued in the response. It is unclear how the technical demands are mutually exclusive when the combined teachings of Thai, Cai, and Sugawara suggest improved skin care moisturizing using similar compositions, whether applied to skin as a traditional cosmetic composition or from a glove.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 8, 9, 10, 11, 14, 15, 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cai, CN 106361680 A in view of Thai, US 20150135404 and Sugawara, US 20140088040 (all cited previously).
Cai teaches a glove comprising a skin protecting layer, i.e., coating, wherein the skin protecting layer comprises hyaluronate, glycerin and butylene glycol (Cai, e.g., claim 1, 0012, and 0020). Cai teaches a method for providing a skin care glove, the method comprising applying the solution to the glove and drying (Cai, e.g., claim 3 and 0021).
Cai teaches the skin protecting layer having a combination of sodium hyaluronate, glycerin and butanediol, wherein the amounts are: Hyaluronate sodium 8-12 parts, Glycerine 10-12 parts, and Butanediol 5-9 parts.
Cai teaches amounts for glycerin (10-12 parts) which are close to the claimed range (13-17 mass parts). Cai teaches an amount of butanediol (5-9) which overlaps with the claimed range (1-5). Cai does not expressly teach the amount of sodium hyaluronate is 0.13-0.17.
Thai teaches a glove comprising a coating containing glycerin and sodium hyaluronate (Thai, e.g., example 2, 0045). Thai teaches wearing gloves causes drying, irritation, and skin discomfort on the user’s hand. Thai proposes providing the glove with a moisturizing composition (Thai, e.g., 0028). Thai teaches wherein the glove is nitrile (Thai, e.g., claim 2). Thai suggests the moisturizing coating further comprise butylene glycol in an amount of about 5-20wt% based on the total weight of the composition (Thai, e.g., 0028). The claimed amounts of butylene glycol and glycerine are within the range generally suggested by Thai. For example, 16 mass parts reads on 16% and 5 mass parts reads on 5%. Thai teaches preparing the coating using a 1% sodium hyaluronate solution (Thai, e.g., example 2, Table 1).
Sugawara teaches working with sodium hyaluronate solutions is improved using a sodium hyaluronate concentration of 1 wt% or less because above this value the viscosity is too high causing handling problems (Sugawara, e.g., 0096). Sugawara teaches optimizing the relative amounts of hyaluronate and polyvalent alcohols since hyaluronate is expensive and a lesser amount of hyaluronate is required to achieve similar skin moisturizing effect in combination with polyvalent alcohols such as glycerin and butylene glycol (Sugawara, e.g., 0013).
It would have been obvious before the effective filing date of the presently claimed invention to combine the teachings of Cai, Thai and Sugawara to arrive at a coating on the interior of a glove having 0.13-0.17 mass parts sodium hyaluronate, 10-12 mass parts glycerin, and 5-9 mass parts butanediol with a reasonable expectation of success. Starting from Cai: the skilled artisan would have been motivated to use a 1% sodium hyaluronate solution as suggested by Thai and Sugawara to prepare the 10-12 mass parts sodium hyaluronate coating for improved handling as reported by Sugawara. Further motivated by Sugawara, the skilled artisan would have found the lowest effective amount of sodium hyaluronate to reduce production costs. Since Sugawara suggests less sodium hyaluronate is needed to achieve similar skin moisturizing effects when used in combination with polyvalent alcohols like glycerin and butylene glycol, the skilled artisan would have had a reasonable expectation of successfully optimizing the amounts of sodium hyaluronate, glycerin, and butylene glycol to coat the interior of a glove for effective skin care to address the dry skin and skin irritation need identified in Thai.
Modifying Cai according to the teachings of Thai and Sugawara, the skilled artisan would have started with a 1% sodium hyaluronate solution in an amount 8-12 parts for Cai’s recipe to reduce cost and improve handling and mixing of the sodium hyaluronate as reported by Sugawara. This would have led the skilled artisan to a coating like Cai’s having a dried sodium hyaluronate mass parts ranging from about 0.08 to about 0.12 parts because 1% of 8 is 0.08 and 1% of 12 is 0.12 and drying removes the excess water. The combined teachings of Cai, Thai and Sugawara suggest a glove containing a skin care composition having sodium hyaluronate in an amount ranging from 0.08-0.12 parts by mass, glycerine 10-12 parts, and butanediol 5-9 parts.
The prior art amounts are very close to those claimed.
A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). MPEP 2144.05.
Moreover, the skilled artisan understood the amounts of hyaluronate and glycerin and butylene glycol could be optimized while retaining desired skin care moisturizing effect. That is, the amount of hyaluronate and glycerin and butylene glycol were parameters recognized in the art as effective to achieve desired moisturizing results. For example, Sugawara taches sodium hyaluronate provides effective moisturizing effect when present in skin contacting compositions in an amount ranging from 0.01-2.0wt% (Sugawara, e.g., claim 2 and 0058). Sugawara teaches optimizing the relative amounts of hyaluronate and polyvalent alcohols since hyaluronate is expensive and a lesser amount of hyaluronate is required to achieve similar skin moisturizing effect in combination with polyvalent alcohols such as glycerin and butylene glycol (Sugawara, e.g., 0013). Moreover, Sugawara teaches the amount of polyvalent alcohol, e.g., glycerin, and/or butylene glycol, may vary over a broad range (Sugawara, e.g., 0051 and 0098).
The recited mass parts read on compositions containing amounts suggested by Thai and Sugawara in percent by mass. According to composition A1 in the specification, when considering the parts as a whole, it is evident that the amount of sodium hyaluronate in A1 is about 1% (0.16/16.16X100%), the amount of glycerin in A1 is about 86% (14/16.16x100%) and the amount of butylene glycol in A1 is about 12.37% (2/16.16x100%). These values are within the ranges suggested by Thai and Sugawara as effective moisturizing amounts for sodium hyaluronate (0.1 to 1.0wt% in Sugawara, e.g., 0059), glycerin (greater than 50wt%, e.g., greater than 80wt% in Sugawara, e.g., 0051) and Thai, e.g., butylene glycol ranging from 5-20wt%. Thai teaches butylene glycol may be effective when present in the range of from 5-20% (Thai, e.g., 0028). The claimed amounts of butylene glycol and glycerine are within the range generally suggested by Thai. For example, 16 mass parts reads on 16% and 5 mass parts reads on 5%. Sugawara clearly teaches the combination of glycerin and butylene glycol (Sugawara, e.g. Fig. 3) and suggests the amount of butylene glycol may vary over a broad range, e.g., from zero to 49.7% or from zero to 89.4% depending on the amount of glycerin in the composition Sugawara, e.g., Fig. 3 and 0051 and 0098 when glycerin is present in a mixture.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
The claimed mass parts are similar to those of Cai optimized according to Thai and Sugawara, and further read on the percent by mass ranges suggested by Thai and Sugawara for moisturizing effect. There does not appear to be any evidence of criticality or unexpected result commensurate in scope with the claimed invention.
Accordingly, the subject matter of claims 1, 8, 9, 10, 11, 14, 15, 16, 17, and 18 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615